A Medical Device Daily

In what is described as a "groundbreaking" advance, French neurosurgeons have successfully treated brain tumors through ultra-keyhole surgery, using a tiny fiber-optic laser to destroy cancerous cells.

A report by the French news agency, AFP, quoted Alexandre Carpentier, MD, of Pitie-Salpetriere Hospital (Paris), as saying that the exploit was "a world first" in its use of multiple advanced techniques and of local anesthesia rather than general sedation.

Carpentier told AFP that thus far, eight volunteers have been treated in the pilot program, launched in December 2006.

"They were suffering from metastasing brain tumors caused by various cancers, mainly lung and breast cancer that failed to respond to conventional treatment and were otherwise inoperable," he said.

AFP's Brigitte Castelnau said in her story that doctors had given the patients involved only three months to live, on average. The pilot trial, reported in the latest issue of the journal Neurosurgery, was carried out under the supervision of the French Health Products Safety Agency.

It drew on technology supplied by the University of Texas M.D. Anderson Cancer Center (Houston), and a Texas company, BioTex (also Houston) which specializes in the use of lasers for medical therapy.

According to the AFP story, under the pioneering technique a tiny hole 3 mm (0.12") wide is drilled into the skull, allowing the surgeon to introduce a water-cooled fiber-optic laser into the brain. The device is guided toward the tumor area with the help of an MRI scanner.

Castelnau reported that every three seconds, a computer workstation calculates the temperature at the area being burned by the laser to ensure that there was no dangerous overheating and to confirm that only tumorous cells were being destroyed.

The patient received only a local anesthetic, remaining conscious in order to be able to speak to the medical team to help verify that cerebral functions were not being harmed.

However, "the patients feels nothing during the operation and generally can leave [the] hospital 14 hours later, the evening or the morning after the operation," Carpentier told AFP. The results are "conclusive," the surgeon said.

Treating the patients completely requires two or more bouts of surgery, and there have been no cases of cerebral bruising or epilepsy. Castelnau's report said that so far, six of the eight volunteers have completed the full program. Of the six, five have not had a relapse — a return of cancerous cells to the brain — at a nine-month monitoring point.

"This is the first time that laser technology has been used intracranially ... using MRI in real time to avoid collateral damage," Carpentier said. "This is the forerunner of future techniques in which MRI will play a core intervention role in neurosurgery."

CE-mark requirements met by Hoana

Hoana Medical (Honolulu, Hawaii) said it has completed the intensive regulatory audits for ISO 13485 and the Medical Device Directive (for most European Union countries), which allows the use of the CE mark for its LifeBed Patient Vigilance System.

The company said this expands its market to include more than 30 countries in the European Union (EU). Hoana previously received FDA clearance in the U.S.

Traditionally, obtaining CE-mark certification and approval is a 12- to 18-month process, but Hoana said it completed the certification process in less than six months.

"We are thrilled to have obtained the CE mark for the LifeBed Patient Vigilance System," said CEO Dr. Patrick Sullivan. "We have received tremendous interest in the LifeBed from hospitals all over Europe and will now be able to partner with them to bring ... 24-hour vigilance to their various hospital units."

He added that "In the U.S., our experience shows that something as simple as finding patients in trouble early makes an enormous difference in their outcome. Using something as simple as the LifeBed to find patients in trouble is clearly enhancing the effectiveness of rapid response teams nationwide."

Hoana said that in a recent study, four out of five European citizens viewed medical errors as an "important problem" in their country, with Italy, Poland and Lithuania leading the way.

The LifeBed technology invisibly tracks a patient's basic vital signs without any connection to the patient whatsoever. If the patient begins to deteriorate, the LifeBed immediately notifies the nursing staff.

Hoana said that changes in a patient's condition due to medications, changes in physiologic conditions or other treatments are identified early by the LifeBed, which results in early interventions. It said the LifeBed also has helped reduce patient falls from hospital beds by as much as 90%.

Zila adds to European distributor rolls

Zila (Phoenix) said it has selected Dentaid (Southampton, UK) to be the exclusive distributor of ViziLite Plus with TBlue, Zila's oral cancer screening product, in Spain, France, Germany and Portugal.

The U.S. firm said Dentaid is the market leader among dental distributors in France and Spain, and has recently established a "significant presence" in the German market. Terms of the agreement were not disclosed.

ViziLite Plus with TBlue is now available to 55% of the residents of Western and Eastern European member countries of the European Union. Zila previously reported the selection of distributors for the product in the UK, Ireland, Greece and Cyprus.

The product is Zila's flagship product for the early detection of oral abnormalities that could lead to cancer. The company said it is the first and only adjunctive medical device cleared by the FDA for use in a population at increased risk for oral cancer.

"ViziLite Plus is a much-needed oral cancer screening product for the practitioners that we call on," said Enric Masdevall, president/CEO of Dentaid Europe. "ViziLite Plus is a proven technology and will be a valuable aid in screening for precancerous lesions and early stage cancers before they reach more severe stages."